U.S. patent application number 12/122229 was filed with the patent office on 2009-11-19 for biopsy device.
Invention is credited to William Krimsky, Michael J. Lee, Brad A. Snow.
Application Number | 20090287114 12/122229 |
Document ID | / |
Family ID | 41316827 |
Filed Date | 2009-11-19 |
United States Patent
Application |
20090287114 |
Kind Code |
A1 |
Lee; Michael J. ; et
al. |
November 19, 2009 |
BIOPSY DEVICE
Abstract
Aspects of the present invention are generally directed to a
biopsy device configured to engage target tissue within a patient
and to remove a sample of the target tissue from the patient. The
biopsy device comprises an elongate catheter configured to be
inserted into a patient. A coring component is disposed at the
distal end of the catheter to sample the target tissue.
Inventors: |
Lee; Michael J.; (US)
; Snow; Brad A.; (US) ; Krimsky; William;
(US) |
Correspondence
Address: |
Connolly Bove Lodge & Hutz LLP
Suite 1100, 1875 Eye Street, NW
Washington
DC
20006
US
|
Family ID: |
41316827 |
Appl. No.: |
12/122229 |
Filed: |
May 16, 2008 |
Current U.S.
Class: |
600/566 ;
600/564; 600/567 |
Current CPC
Class: |
A61B 10/04 20130101;
A61B 2017/306 20130101; A61M 2025/0197 20130101; A61B 10/0266
20130101; A61B 10/06 20130101; A61B 2017/3488 20130101 |
Class at
Publication: |
600/566 ;
600/567; 600/564 |
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Claims
1. A device for sampling target tissue within a patient,
comprising: a coring component having: a longitudinal lumen
terminating in a distal opening; and a distal region formed of one
or more distally extending blades each having a distal end
positioned around said distal opening, wherein said one or more
blades are configured to penetrate the target tissue such that a
tissue sample having a cross-section defined by said distal ends of
said one or more blades is received within said lumen of said
coring component via said distal opening, and wherein said blades
are configured to substantially sever said tissue sample from the
target tissue.
2. The device of claim 1, wherein each said blade has an
approximate lunate cross-section along a lateral axis substantially
parallel to said distal opening.
3. The device of claim 1, wherein said coring component comprises
two or more elongate blades, at least one of said blades configured
to flex inwardly towards a longitudinal axis of said coring
component in response to penetration of the target tissue by said
blades.
4. The device of claim 4, wherein a distal region of at least one
of said blades opposing said lumen of said coring component
comprises a beveled surface.
5. The device of claim 1, wherein said coring component comprises
two or more elongate blades, each of said blades configured to flex
inwardly towards a longitudinal axis of said coring component
following penetration of the target tissue by said blades.
6. The device of claim 5, wherein at least one of said blades
comprise a shape memory material responsive to a change in
temperature that occurs following said penetration.
7. The device of claim 5, wherein at least one of said blades
comprise a shape memory material responsive to an applied
electrical current.
8. The device of claim 3, wherein said coring component comprises
two or more separate elements defining said lumen, and wherein said
elements are connected by a hinge arrangement.
9. The device of claim 8, wherein said hinge arrangement may be
actuated so as to cause at least one of said blades to flex
inwardly towards said longitudinal axis.
10. The device of claim 1, wherein said device further comprises an
elongate catheter having proximal and distal ends and a lumen
longitudinally extending there through, wherein said coring
component is disposed at said distal end of said catheter, and
wherein said lumen of said catheter that is operationally
contiguous with said lumen of said coring component.
11. The device of claim 1, further comprising: an anchoring element
configured to secure the device to the target tissue.
12. The device of claim 11, wherein said anchoring element
comprises an element disposed on a distal end of at least one of
said one or more blades.
13. The device of claim 11, wherein said anchoring element is
configured to be controllably extended from within said coring
component to secure the device to the target tissue.
14. The device of claim 11, wherein said anchoring element is
configured to be controllably extended around said coring component
to secure the device to the target tissue.
15. The device of claim 13, wherein said anchoring element
comprises an extendible needle.
16. The device of claim 11, wherein said anchoring element
comprises an extendible needle.
17. The device of claim 1, wherein said anchoring element comprises
a suction system configured to secure said catheter.
18. The device of claim 1, wherein said coring component further
comprises at least one tissue retention feature configured to
secure said tissue sample within said lumen of said coring
component.
19. The device of claim 18, wherein said at least one tissue
retention feature comprises: a textured surface of a portion of at
least one of said one or more blades adjacent said lumen of said
coring component.
20. The device of claim 18, wherein said at least one tissue
retention feature comprises: an adhesive having an adhesion force
that may be overcome with sufficient manual force.
21. The device of claim 18, wherein said at least one tissue
retention feature comprises: a barb disposed on at least one of
said one or more blades adjacent said lumen of said coring
component.
22. The device of claim 18, wherein said device further comprises
an elongate catheter having proximal and distal ends and a lumen
longitudinally extending there through, wherein said coring
component is disposed at said distal end of said catheter, and
wherein said at least one tissue retention feature comprises a
suction system configured to provide suction via said catheter.
23. The device of claim 22, wherein said suction is provided
through said coring component.
24. The device of claim 22, wherein said suction is provided around
said coring component.
25. The device of claim 24, wherein a distal region of said sheath
has a fixed radius of curvature.
26. The device of claim 1, wherein said blades are configured to
anchor the device to the target tissue.
27. The device of claim 1, further comprising an endoscopic device
having: an elongate catheter having proximal and distal ends and a
lumen longitudinally extending there through, wherein said coring
component is disposed at said distal end of said catheter; and a
sheath configured to be inserted into the patient and configured to
have said catheter inserted therein.
28. The device of claim 27, wherein a distal region of said sheath
has a fixed radius of curvature.
29. The device of claim 28, further comprising: one or more
components configured to controllably curve a distal region of said
sheath.
30. The device of claim 1, further configured to deliver a
treatment to the target tissue.
31. The device of claim 30, wherein said treatment comprises
hemostasis of the target tissue.
32. The device of claim 31, wherein said coring component is
configured to cauterize the target tissue.
33. The device of claim 31, wherein said coring component is
configured to apply a hemostasis coating to the target tissue.
34. The device of claim 30, wherein said treatment comprises
delivery of a therapeutic agent to the target tissue.
35. A coring component configured to sample a target tissue within
a patient, the coring component comprising: a longitudinal lumen
terminating in a distal opening; and a distal region formed of one
or more distally extending blades each having a distal end
positioned around said distal opening, wherein said one or more
blades are configured to penetrate the target tissue such that a
tissue sample having a cross-section defined by said distal ends of
said one or more blades is received within said lumen of said
coring component via said distal opening, and wherein said blades
are configured to substantially sever said tissue sample from the
target tissue.
36. The component of claim 35, wherein each said blade has an
approximate lunate cross-section along a lateral axis substantially
parallel to said distal opening.
37. The component of claim 35, further comprising two or more
elongate blades, at least one of said blades configured to flex
inwardly towards a longitudinal axis of said coring component in
response to penetration of the target tissue by said blades.
38. The component of claim 37, wherein a distal region of at least
one of said blades opposing said lumen of said coring component
comprises a beveled surface.
39. The component of claim 35, further comprising two or more
elongate blades, at least one of said lumen connected by a
longitudinal axis of said coring component following penetration of
the target tissue by said blades.
40. The component of claim 38, wherein at least one of said blades
comprise a shape memory material responsive to a change in
temperature that occurs following said penetration.
41. The component of claim 38, wherein at least one of said blades
comprise a shape memory material responsive to an applied
electrical current.
42. The component of claim 37, further comprising two or more
separate elements defining said lumen connected by a hinge
arrangement.
43. The component of claim 42, wherein said hinge arrangement may
be actuated so as to cause at least one of said blades to flex
inwardly towards said longitudinal axis.
44. The component of claim 35, wherein said coring component is
disposed on the distal end of a catheter having a lumen
longitudinally extending there through that is operationally
contiguous with said lumen of said coring component.
45. The component of claim 35, further comprising: an anchoring
element configured to secure the component to the target
tissue.
46. The component of claim 45, wherein said anchoring element
comprises an element disposed on a distal end of at least one of
said one or more blades.
47. The component of claim 45, wherein said anchoring element is
configured to be controllably extended from within said coring
component to secure the component to the target tissue.
48. The component of claim 45, wherein said anchoring element is
configured to be controllably extended around said coring component
to secure the component to the target tissue.
49. The component of claim 47, wherein said anchoring element
comprises an extendible pair of opposing jaws.
50. The component of claim 47, wherein said anchoring element
comprises an extendible needle.
51. The component of claim 44, wherein said catheter is configured
to provide suction through said coring component to secure the
component to the target tissue.
52. The component of claim 35, further comprising at least one
tissue retention feature configured to secure said tissue sample
within said lumen of said coring component.
53. The component of claim 52, wherein said at least one tissue
retention feature comprises: a textured surface of a portion of at
least one of said one or more blades adjacent said lumen of said
coring component.
54. The component of claim 47, wherein said at least one tissue
retention feature comprises: an adhesive having an adhesion force
that may be overcome with sufficient manual force.
55. The component of claim 52, wherein said at least one tissue
retention feature comprises: a barb disposed on at least one of
said one or more blades adjacent said lumen of said coring
component.
56. The component of claim 44, wherein said catheter is configured
to provide suction to secure said sample to said component.
57. The component of claim 56, wherein said suction is provided
through said coring component.
58. The device of claim 56, wherein said suction is provided around
said coring component.
59. The component of claim 35, wherein at least one of said blades
are configured to anchor the coring component to the target
tissue.
60. The component of claim 44, wherein said component is configured
to be removably attached to said catheter.
61. The component of claim 35, further configured to deliver a
treatment to the target tissue.
62. The component of claim 61, wherein said treatment comprises
hemostasis of the target tissue.
63. The component of claim 62, wherein said coring component is
configured to cauterize the target tissue.
64. The component of claim 62, wherein said coring component is
configured to apply a hemostasis coating to the target tissue.
65. The component of claim 61, wherein said treatment comprises
delivery of a therapeutic agent to the target tissue.
66. A method for obtaining a tissue sample from a target tissue in
a patient with a device having a coring component disposed at a
distal end thereon, the coring component having a longitudinal
lumen terminating in a distal opening, a distal region formed of
one or more distally extending blades each having a distal end
positioned around said distal opening, the method comprising:
positioning said coring component such that said distal ends of
said blades are adjacent the target tissue; penetrating the target
tissue with said blades such that a tissue sample having a
cross-section defined by said distal ends of said one or more
blades is received within said lumen of said coring component via
said distal opening, and substantially severing said tissue sample
from the target tissue.
67. The method of claim 66, wherein substantially severing said
tissue portion comprises: rotating said coring component about a
longitudinal axis through the geometric center of center of said
opening so as to reduce the cross-sectional area of said tissue at
said opening.
68. The method of claim 66, wherein said component comprises two or
more elongate blades, one or more of said blades configured to flex
inwardly towards a longitudinal axis of said coring component in
response to penetration of the target tissue by said blades.
69. The method of claim 68, wherein a distal region of at least one
of said blades opposing said lumen of said coring component
comprises a beveled surface.
70. The method of claim 66, wherein said coring component comprises
two or more elongate blades, at least one of said blades configured
to flex inwardly towards a longitudinal axis of said coring
component following penetration of the target tissue by said
blades.
71. The method of claim 70, wherein at least one of said blades
comprise a shape memory material responsive to a change in
temperature that occurs following said penetration.
72. The method of claim 70, wherein at least one of said blades
comprise a shape memory material responsive to an applied
electrical current.
73. The method of claim 68, wherein said coring component comprises
two or more separate elements defining said lumen, and wherein said
elements are connected by a hinge arrangement.
74. The method of claim 73, further comprising: actuating said
hinge arrangement so as to cause at least one of said blades to
flex inwardly towards said longitudinal axis.
75. The method of claim 66, further comprising: anchoring said
device to the target tissue.
76. The method of claim 66, wherein anchoring said device
comprises: extending an anchoring element from said coring
component to the target tissue; and securing said component to the
target tissue with said extendible anchoring element.
77. The method of claim 76, wherein extending said anchoring
element comprises: extending said anchoring element from within
said coring component.
78. The method of claim 76, wherein extending said anchoring
element comprises: extending said anchoring element around said
coring component.
79. The method of claim 76, wherein said anchoring element
comprises a pair of extendible opposing jaws.
80. The method of claim 76, wherein said anchoring element
comprises an extendible needle.
81. The method of claim 75, wherein said coring component has an
anchoring element disposed on a distal end of at least one of said
one or more blades, and wherein anchoring said component comprises:
securing said anchoring element disposed at said at least one
distal end to the target tissue.
82. The method of claim 75, wherein said device comprises a suction
system configured to provide suction through said coring component,
and wherein anchoring said component comprises: securing said
component to the target tissue with said suction.
83. The method of claim 75, wherein said device comprises a suction
system configured to provide suction around said coring component,
and wherein anchoring said component comprises: securing said
component to the target tissue with said suction.
84. The method of claim 66, further comprising: securing said
tissue sample to said coring component to retain said severed
tissue portion within said lumen of said coring component.
85. The method of claim 84, wherein at least a portion of at least
one of said one or more blades adjacent said lumen of said coring
component comprises a textured surface, and wherein securing said
tissue sample within said lumen of said coring component comprises:
securing said textured surface to said tissue sample.
86. The method of claim 84, wherein at least a portion of at least
one of said one or more blades adjacent said lumen of said coring
component has an adhesive disposed thereon having an adhesion force
that may be overcome with sufficient manual force, and wherein
securing said tissue sample within said lumen of said coring
component comprises: securing said adhesive to said tissue
sample.
87. The method of claim 84, wherein said coring component has a
barb disposed thereon, and wherein securing said tissue sample
within said lumen of said coring component comprises: securing said
barb to said tissue sample.
88. The method of claim 84, wherein said device comprises a suction
system configured to provide suction through said coring component,
and wherein securing said tissue sample within said lumen of said
coring component comprises: securing said tissue sample with said
suction.
89. The method of claim 89, wherein said suction is provided
through said coring component.
90. The method of claim 88, wherein said suction is provided around
said coring component.
91. The method of claim 66, wherein said catheter has a lumen
longitudinal extending there through that is operationally
contiguous with said lumen of said coring component, and wherein
said method further comprises: delivering a treatment to the target
tissue via said contiguous lumens.
92. The method of claim 91, wherein delivering said treatment
comprises: applying a hemostasis treatment to the target
tissue.
93. The method of claim 92, applying a hemostasis treatment to the
target tissue comprises: cauterizing the target tissue with said
coring component.
94. The method of claim 92, applying a hemostasis treatment to the
target tissue comprises: applying a hemostasis coating to the
target tissue.
95. The method of claim 91, wherein delivering said treatment
comprises: delivering of a therapeutic agent to the target
tissue.
96. The method of claim 91, wherein delivering said treatment
comprises: suturing the target tissue.
97. The method of claim 91, wherein delivering said treatment
comprises: inserting a marker into the target tissue.
98. The method of claim 91, wherein delivering said treatment
comprises: inserting a diagnostic agent into the target tissue.
Description
BACKGROUND
[0001] 1. Field of the Invention
[0002] The present invention relates generally to a tissue-sampling
device, and more particularly, to a biopsy device.
[0003] 2. Related Art
[0004] For various medical reasons, such as diagnostic tests and
the like, it is often necessary for a physician, surgeon or other
medical practitioner (generally referred to hereinafter as a
"surgeon") to obtain a sample of a patient's body. During these
sampling or biopsy procedures, the samples may be taken from a
variety of organs and other soft tissue, or from a more rigid
structure such as a bone or bone marrow.
[0005] There are a variety of medical procedures to obtain a tissue
sample. For example, an endoscopic procedure commonly referred to
as an endoscopic biopsy procedure, is often used to obtain tissue
samples within a patient's body. During an endoscopic biopsy
procedure, a sample of a target tissue is removed from a patient
with an endoscopic biopsy device having a tissue acquisition
element. The endoscopic biopsy device may include an elongate tube
having a lighted camera on a distal end, collectively referred to
as an endoscope or endoscope camera, that is used by the surgeon to
view the target tissue during the biopsy procedure. Other devices
or systems for visualizing the sampling procedure may also be used.
For example, any radiographic, fluoroscopic, or other navigational
or guidance modality, including COT, may also be used for
visualizing the sampling procedure.
[0006] In certain devices, the biopsy or tissue acquisition element
may be passed through a catheter that is separate from the tube
having a camera thereon. Likewise, other devices may also be
inserted through or around the endoscope.
[0007] A sample of the target tissue is generally taken using a
brush or a needle attached to a cable within the endoscopic device.
Following sampling of the target tissue, the tissue sample is
removed from the patient and examined. The tissue is generally
examined under a microscope by a pathologist or chemically analyzed
using, for example, gas chromatography techniques.
[0008] Depending on the target tissue and other physical conditions
or circumstances, sampling of internal tissue may be difficult or
may require skill to quickly and efficiently obtain an adequate
tissue sample to permit proper examination by a pathologist or
other medical practitioner.
SUMMARY
[0009] In one aspect of the present invention, a device for
sampling target tissue within a patient is provided. The device
comprises: a coring component having: a longitudinal lumen
terminating in a distal opening; and a distal region formed of one
or more distally extending blades each having a distal end
positioned around the distal opening, wherein the one or more
blades are configured to penetrate the target tissue such that a
tissue sample having a cross-section defined by the distal ends of
the one or more blades is received within the lumen of the coring
component via the distal opening, and wherein the blades are
configured to substantially sever the tissue sample from the target
tissue.
[0010] In another aspect of the present invention, a coring
component configured to sample a target tissue within a patient is
provided. The coring component comprises: a longitudinal lumen
terminating in a distal opening; and a distal region formed of one
or more distally extending blades each having a distal end
positioned around the distal opening, wherein the one or more
blades are configured to penetrate the target tissue such that a
tissue sample having a cross-section defined by the distal ends of
the one or more blades is received within the lumen of the coring
component via the distal opening, and wherein the blades are
configured to substantially sever the tissue sample from the target
tissue.
[0011] In another aspect of the present invention a method for
obtaining a tissue sample from a target tissue in a patient with a
coring component having a longitudinal lumen terminating in a
distal opening, a distal region formed of one or more distally
extending blades each having a distal end positioned around the
distal opening is provided. The method comprises: positioning the
coring component such that the distal ends of the blades are
adjacent the target tissue; penetrating the target tissue with the
blades such that a tissue sample having a cross-section defined by
the distal ends of the one or more blades is received within the
lumen of the coring component via the distal opening, and
substantially severing the tissue sample from the target
tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] Illustrative embodiments of the present invention are
described herein with reference to the accompanying drawings, in
which:
[0013] FIG. 1 is a perspective view of a distal end of an exemplary
biopsy device in accordance with embodiments of the present
invention;
[0014] FIG. 2A is a high-level flowchart illustrating an exemplary
sampling procedure in accordance with embodiments of the present
invention;
[0015] FIG. 2B is a mid-level flowchart illustrating the obtaining
a sample of a target tissue in accordance with embodiments of block
204 of FIG. 2A;
[0016] FIG. 3A is a detailed flowchart illustrating the engagement
of a sampling component with a target tissue in accordance with one
particular embodiment of block 220 of FIG. 2B;
[0017] FIG. 3B is a detailed flowchart illustrating the engagement
of a sampling component with a target tissue in accordance with one
particular embodiment of block 220 of FIG. 2B;
[0018] FIG. 4A is a simplified side view of one embodiment of
components of a biopsy device which may be used by a surgeon to
position a sampling component at a desired location within a
patient;
[0019] FIG. 4B is a simplified side view of the embodiment of
components of a biopsy device shown in FIG. 4A in which the distal
region of the device is shown in a curved configuration;
[0020] FIG. 4C is a simplified side view of one embodiment of
components of a biopsy device which may be used by a surgeon to
position a sampling component at a desired location within a
patient;
[0021] FIG. 5 is a perspective view of a biopsy device having a
jaws arrangement for sampling a target tissue within a patient in
accordance with embodiments of the present invention;
[0022] FIG. 6 is a perspective view of a biopsy device having a
coring component for sampling a target tissue within a patient in
accordance with embodiments of the present invention;
[0023] FIG. 7A is a front perspective view of a coring component in
accordance with one embodiment of the present invention;
[0024] FIG. 7B is a perspective view of a coring component in
accordance with one embodiment of the present invention;
[0025] FIG. 7C is a perspective view of a coring component in
accordance with one embodiment of the present invention;
[0026] FIG. 8A is a side perspective view of a coring component in
accordance with one embodiment of the present invention;
[0027] FIG. 8B is a side perspective view of a coring component in
accordance with one embodiment of the present invention;
[0028] FIG. 9 is a front perspective view of a biopsy device having
an anchoring element in accordance with embodiments of the present
invention;
[0029] FIG. 10A is a front perspective view of a biopsy device
having an anchoring element in accordance with one embodiment of
the present invention;
[0030] FIG. 10B is a front perspective view of the embodiment of a
biopsy device shown in FIG. 10A;
[0031] FIG. 11A is a perspective view of a biopsy device having an
anchoring element in accordance with one embodiment of the present
invention;
[0032] FIG. 11B is a perspective view of the embodiment of a biopsy
device shown in FIG. 11A;
[0033] FIG. 12A is a front perspective view of a biopsy device
having an anchoring element in accordance with one embodiment of
the present invention;
[0034] FIG. 12B is a perspective view of the embodiment of a biopsy
device shown in FIG. 12A;
[0035] FIG. 13A is a front perspective view of a biopsy device
having an anchoring element in accordance with one embodiment of
the present invention;
[0036] FIG. 13B is a front perspective view of a biopsy device
having an anchoring element in accordance with one embodiment of
the present invention; and
[0037] FIG. 13C is a front perspective view of a biopsy device
having an anchoring element in accordance with one embodiment of
the present invention.
DETAILED DESCRIPTION
[0038] Aspects of the present invention are generally directed to a
biopsy device having a coring component configured to engage target
tissue of a patient and to remove a sample of the target tissue
from the patient. The coring component comprises a longitudinal
lumen terminating in a distal opening. A distal region of the
coring component is formed of one or more distally extending blades
each having a distal end positioned around the distal opening of
the lumen. The blades are configured to penetrate the target tissue
such that a tissue sample having a cross-section defined by the
distal ends of the one or more blades is received within the lumen
of the coring component via the distal opening. The blades are
configured to substantially sever the tissue sample from the
remainder of the target tissue.
[0039] In certain embodiments, the coring component comprises two
or more elongate blades each having distal ends positioned around
the distal opening. In some embodiments, to sever the tissue, one
or more of the blades flex inwardly towards a longitudinal axis of
the coring component. In the same or other embodiments, the coring
component is rotatable relative to the target tissue to facilitate
the severing of the tissue sample. In particular embodiments of the
present invention, the biopsy device comprises an anchoring element
which secures the device to the target tissue. In certain
embodiments, the biopsy device may further include a tissue
retention feature which secures the tissue sample in the lumen of
the coring component.
[0040] FIG. 1 is a perspective view of a distal region of an
exemplary biopsy device 100 that may be used to sample a target
tissue within a patient in accordance with embodiments of the
present invention. Although the present invention will be discussed
herein with reference to specific types of biopsy devices and
procedures, namely endoscopic biopsy devices and procedures, it
should be appreciated that embodiments of the present invention may
be used in conjunction with any other biopsy or tissue sampling
device/procedure.
[0041] In certain optional embodiments of the present invention,
biopsy device 100 comprises a tube or sheath 102 which is
introduced into the patient to facilitate the positioning of
sampling component 150 adjacent target tissue 130. The target
tissue comprises a tissue which the surgeon desires to obtain a
sample thereof. In accordance with embodiments of the present
invention, the target tissue may be a portion of a tissue, bone or
organ surface, a portion of the tissue, bone or organ lying beneath
the surface, or any other portion of a tissue, organ or bone.
[0042] In embodiments in which sheath 102 is provided, catheter 104
may be introduced into a lumen 108 of sheath 102. As would be
appreciated, catheter 104 may be introduced into lumen 108 during a
biopsy procedure or catheter 104 may be preoperatively positioned
within lumen 108. Regardless whether catheter 104 is introduced
into lumen 108 prior to or during a biopsy procedure, it should be
appreciated that catheter 104 is movable within sheath 102 and may
be extended from a distal end of the sheath.
[0043] FIG. 1 illustrates an embodiment of biopsy device 100 in
which catheter 104 extends from the distal end of sheath 102. In
the illustrated embodiment, a sampling component 150 is integrated
at the distal end of catheter 104. Sampling component 150 is
configured to obtain a sample of a patient's target tissue 130.
[0044] FIG. 2A is a high-level flowchart illustrating a surgical
procedure 210 for obtaining a tissue sample from a patient with an
endoscopic biopsy device, in accordance with embodiments of the
present invention. At block 202, a sampling component is positioned
adjacent a target tissue within the patient. Embodiments of a
biopsy device having components to position a sampling component
adjacent the target tissue are described below with reference to
FIGS. 4A-4C.
[0045] At block 204, the sampling component is used to obtain a
tissue sample from the target tissue. Obtaining a tissue sample is
described in more detail below with reference to FIG. 2B. At block
206, after a tissue sample is obtained, the sampling component and
the tissue sample are removed from the patient.
[0046] FIG. 2B is a mid-level flowchart illustrating the operations
performed to obtain a tissue sample in accordance with embodiments
of block 204 of FIG. 2A. At block 220, the sampling component
engages the target tissue. FIGS. 3A and 3B illustrate various
embodiments for engaging the target tissue with the sampling
component.
[0047] At block 222, the sampling component substantially severs a
portion of the tissue sample from the remainder if the target
tissue. Substantial severing of the tissue sample from the target
tissue is described below with reference to FIGS. 7A-8B. At block
224, the severed tissue sample is extracted from the target
tissue.
[0048] FIG. 3A is a flowchart illustrating particular embodiments
of block 220 of FIG. 2B in which a sampling component of a biopsy
device engages the target tissue. In this embodiment, the sampling
component comprises a coring component configured to penetrate a
target tissue and to extract a tissue sample from the target
tissue. At block 330 the biopsy device is anchored or secured to
the target tissue by, for example, an anchoring element. The device
may be secured to the target tissue to ensure that a desired
portion of the target tissue is sampled by the coring
component.
[0049] Following anchoring of the biopsy device to the target
tissue, at block 332 the coring component penetrates the target
tissue. As detailed further below, a surgeon may operate the biopsy
device so as to cause the distal end of the coring component to
penetrate the target tissue.
[0050] FIG. 3B is a flowchart illustrating certain other
embodiments of block 220 of FIG. 2B in which a coring component is
engaged with the target tissue. In the embodiments illustrated in
FIG. 3B, the biopsy device includes an anchoring element in the
form of an extendible anchor. As described in more detail below, in
alternative embodiments the anchoring element may be attached to,
or comprise part of the coring component. In certain embodiments,
the anchoring element may comprise the coring component itself that
is extended out a controlled distance. As shown, at block 340 the
anchor may be extended from the biopsy device to the target tissue.
In accordance with embodiments discussed below, at block 342 at
least a portion of the anchor is secured or affixed to the target
tissue.
[0051] After the anchor is secured to the target tissue, the coring
component is extended to target tissue at block 344. At block 346,
the coring component penetrates the target tissue such that a
portion of the target tissue having a cross-section defined by the
distal end of the coring component is received within the coring
component.
[0052] As noted above with reference to block 202 of FIG. 2A, a
distal end of the sampling component is positioned adjacent the
target tissue prior to obtaining a sample of the target tissue. A
biopsy device in accordance with embodiments of the present
invention may include a variety of mechanisms or elements which
permit a surgeon to guide the distal end of the sampling component
to a desired location adjacent the target tissue. FIGS. 4A-4C
illustrates particular optional embodiments of a biopsy device 400
in which a sheath 402 is used to guide the sampling component to a
desired location.
[0053] In the embodiments of FIGS. 4A and 4B, biopsy device 400
includes a sheath 402 having a proximal end 422 and a distal end
420, an endoscope body 410, and articulation elements 430. As would
be appreciated, endoscope body 410 may include a variety of
functional components.
[0054] In the embodiment of FIGS. 4A and 4B, articulation elements
430 provide a surgeon with the ability to guide a sampling
component (not shown) such that a distal end of the sampling
component is adjacent the target tissue. Articulation elements 430
comprise an articulation control section 432 and one or more wires
(not shown). In the illustrated embodiment, articulation control
section 432 is positioned between body 410 and proximal end 422 of
sheath 402. The one or more wires extend from control section 432
through sheath 402 to distal end 420 of sheath 402.
[0055] In the illustrated embodiments of the present invention,
actuation of control section 432 exerts a push or pull force on one
or more of the wires extending between control section 432 and
distal end 420 of sheath 402. The push or pull forces on the wires
cause distal end 420 of sheath 420 to deflect at one or more
angles.
[0056] For example, as shown in FIG. 4A, control section 432 is
positioned in a first configuration and distal end of sheath 402 is
substantially aligned with a longitudinal axis 440 of body 410. As
shown in FIG. 4B, control section 432 is actuated by movement a
distance 412 along axis 440 in the direction of body 410. Actuation
of control section 432 causes distal end 420 to deflect a distance
from longitudinal axis 440. In these embodiments, the magnitude of
the deflection of distal end 420 may be controlled by moving
control section 432 less than distance 412.
[0057] As noted, in the embodiments illustrated in FIGS. 4A and 4B,
control section 432 is configured to slide along axis 440 to exert
push or pull forces on the wires extending to distal end 420.
However, it should be appreciated that control section 432 may be
actuated in a variety of manners. For example, in certain
embodiments control section 432 may comprise a knob configured to
be rotated in or more directions. In these embodiments, the
magnitude of the deflection of distal end 420 is controlled by the
rotation of the knob by the surgeon. In still other embodiments,
control section 432 comprises a dual deflection control. As would
be appreciated by one of ordinary skill in the art, any
conventional mechanism that uses a push/pull, twist, rotation or
other similar motion to actuate, deflect and/or steer distal end
420 may be used in accordance with embodiments of the present
invention.
[0058] In other embodiments of FIGS. 4A and 4B, magnetic fields may
be used to control the deflection of distal end 420. More
specifically, internal magnets incorporated into biopsy device 400,
or external magnets may be used to control the deflection of distal
end 420.
[0059] In additional embodiments, shape memory materials may be
used to cause a deflection of distal end 420. In these embodiments,
upon the occurrence of a predetermined condition, the shape memory
material causes distal end 420 to adopt a desired configuration.
For example, in certain embodiments, shape memory wires may be
included in sheath 402.
[0060] FIG. 4C illustrates alternative embodiments of the present
invention in which articulation elements 432 have been omitted. In
the illustrated embodiment, biopsy device 490 includes a sheath 474
having a proximal end 472 and a distal end 480 and an endoscope
body 470. As would be appreciated, endoscope body 470 may include a
variety of functional components. In certain embodiments
illustrated in FIG. 4C, the magnitude of the deflection of distal
end 480 may be controlled by, for example, a surgeon prior to
insertion of sheath 474 into the patient. In these embodiments, the
surgeon may manually set the magnitude of deflection of distal end
480. In these embodiments, at least a distal region of sheath 474
comprises a material that is flexible enough to be manually curved
by the surgeon to a desired angle, but which has sufficient
strength to maintain the desired angle during the biopsy
procedure.
[0061] In further embodiments, the distal region of sheath 474 may
comprise a shape memory material. In these embodiments, distal end
480 has a first configuration prior to insertion into a patient.
Following insertion of sheath 474, distal end 480 adopts a second
configuration. As would be appreciated by one of ordinary skill in
the art, distal end 480 may adopt the second configuration in
response to, for example, a change in temperature or application of
an electrical current thereto.
[0062] In still other embodiments illustrated in FIG. 4C, the
deflection of distal end 420 is fixed prior to insertion during,
for example, manufacture of sheath 474. In such embodiments, a
distal region of the sheath has a fixed radius of curvature.
[0063] Furthermore, although FIGS. 4A-4C have been described with
reference to deflection of a distal end 420, 480, it should be
appreciated that any other methods now know or later developed for
guiding or steering a sampling component to a location adjacent the
target tissue are also within the scope of the present invention.
It should also be appreciated that use of a sheath in embodiments
of the present invention is optional and not required. For example,
in certain embodiments a guide wire may be introduced into the
patient and used by a surgeon to guide the sampling component to a
location adjacent the target tissue.
[0064] FIG. 5 is a perspective view of a distal region of a biopsy
device 500 in accordance with particular embodiments of the present
invention. As shown in FIG. 5, biopsy device 500 comprises a sheath
502 having a lumen 516 there through. Extending through lumen 516
is an elongate catheter 504 having an integrated sampling component
550 disposed at the distal end thereof configured to obtain a
sample of a target tissue.
[0065] In the illustrated embodiment, sampling component 550
comprises a jaws arrangement 550. In these embodiments, jaws
arrangement 550 comprises a pair of opposing jaws 512 configured to
be positioned around a portion of the target tissue, referred to
herein as a tissue sample. Following positioning of opposing jaws
512 around the tissue sample, the surgeon may actuate jaws 512 so
as to close the jaws about the tissue sample. In certain
embodiments, jaws 512 may have sharpened, serrated or other edges
such that closure of jaws 512 substantially severs the tissue
sample from the remainder of the target tissue. As would be
appreciated by one of ordinary skill in the art, biopsy device 500
may include various components which permit a surgeon to open
and/or close jaws 512.
[0066] FIG. 6 is a perspective view of a distal region of a biopsy
device 600 in accordance with embodiments of the present invention.
Biopsy device 600 is configured to engage target tissue within a
patient and to remove a sample of the target tissue from the
patient.
[0067] As shown in FIG. 6, biopsy device 600 comprises a sheath 602
having an elongate catheter 604 extending there through. An
integrated coring component 650 is disposed at the distal end of
catheter 604 to sample a target tissue. Coring component 650
comprises a longitudinal lumen terminating in a distal opening 606.
The lumen of coring component 650 is operationally contiguous with
the lumen of catheter 604.
[0068] A proximal region of coring component 650, shown as shaft
630, is permanently or removably connected to the distal end of
catheter 604, and a distal region of the coring component is formed
of one or more distally extending blades each having a distal end
positioned around distal opening 606. The blades are configured to
penetrate the target tissue such that a tissue sample having a
cross-section defined by the distal ends of the one or more blades
is received within the lumen of coring component 650 via distal
opening 606. The blades are configured to substantially sever the
tissue sample from the remainder of the target tissue.
[0069] In the embodiments illustrated in FIG. 6, the distal region
of coring component 650 is formed as a blade arrangement 622. Blade
arrangement 622 has one or more cutting edges 618 positioned around
distal opening 606 of coring component 650. Blade arrangement 622
penetrates the target tissue such that a portion of the target
tissue having a cross-section defined by the distal end of blade
arrangement 622 is received within the lumen of coring component
650 via distal opening 606. The portion of the target tissue
received within coring component 650 is referred to herein as a
tissue sample. As described in more detail below, blade arrangement
622 is configured to substantially sever the tissue sample from the
remainder of the target tissue.
[0070] As shown in FIG. 6, blade arrangement 622 has a single
cutting edge substantially surrounding opening 606. FIGS. 7A
through 7C illustrate other embodiments of coring components in
accordance with embodiments of the present invention.
[0071] As noted above, a surgeon positions coring component 650 at
a location such that the distal end of the coring component is
adjacent the target tissue. Coring component 650 is extended to the
target tissue and engaged therewith. As would be appreciated by one
of ordinary skill in the art, biopsy device 600 may include various
components which permit a surgeon to extend coring component 650 to
the target tissue. For example, in certain embodiments, biopsy
device 600 comprises one or more push/pull wires which allow a
surgeon to selectively extend coring component 650. Such push/pull
wires may be controlled, for example, via by thumb knobs or various
other mechanisms.
[0072] In other embodiments, biopsy device 600 could include one or
more shape memory wires. In such embodiments, the length of the
shape memory wires may be controlled so as to selectively extend
coring component 650. The length of such shape memory wires may be
controlled by, for example, by applying an electrical current to
the wires.
[0073] In still other embodiments, a syringe/needle mechanism may
be included in biopsy device 600 to selectively extend coring
component 650. As would be appreciated by one of ordinary skill in
the art, the above mechanisms for extending coring component 650
have been provided for illustration purposes only and any other
known component or mechanism which permits a surgeon to extend the
coring component may also be included in biopsy device 600.
[0074] Although FIG. 6 has been discussed with reference to the use
of one more components to extend coring component 650 to the target
tissue, it should be appreciated that such components are optional
and are not required. For example, in certain embodiments, a
surgeon may manually exert a force on catheter 604 to cause coring
component 650 to be extended to the target tissue.
[0075] As noted above, blade arrangement 622 is configured to
penetrate the target tissue such that a portion of the target
tissue having a cross-section defined the distal end of blade
arrangement 622 is received within the lumen of coring component
650 via distal opening 606. In certain embodiments of the present
invention, blade arrangement 622 penetrates the target tissue in
response to one or both of a longitudinal force exerted on the
coring component 650 in the direction of the target tissue or a
rotational force exerted on coring component 650. These rotational
and/or longitudinal forces on coring component 650 may be applied
in a variety of manners. For example, in certain embodiments, a
surgeon may manually apply a longitudinal or rotational force. In
other embodiments, biopsy device 600 may comprise any known
articulation mechanism or element that permits a surgeon to apply
the desired longitudinal or rotational force.
[0076] Also as noted above, blade arrangement 622 is configured to
substantially sever the tissue sample from the remainder of the
target tissue so that tissue sample suitable for proper examination
is obtained during the sampling procedure. As noted above, certain
sampling devices are unable to obtain large enough samples suitable
for all types of examination. Blade arrangement 622 may sever the
tissue sample in a variety of manners. In the specific embodiment
of FIG. 6, blade arrangement 622 substantially severs the portion
of target tissue positioned within coring component 650 via, for
example, rotation of coring component 650 about a longitudinal axis
extending through opening 606. In response to the rotation of
coring component 650, the distal end of blade arrangement 622
substantially reduces the cross-section of the portion of the
target tissue positioned proximate to opening 606. As described
below in more detail with reference to FIG. 7, coring component 650
may be rotated manually by a surgeon or through the use of one or
more elements included within biopsy device 600.
[0077] As explained above with reference to FIG. 2B, after the
tissue sample has been substantially severed from the remainder of
the target tissue, the tissue sample may be extracted from the
target tissue by removing coring component 650 from the target
tissue. Because, in certain embodiments, blade arrangement 622
substantially severs the tissue sample, the tissue sample may
remain partially attached to the remainder of the target tissue. As
discussed below in more detail, coring component 650 is configured
to firmly secure the tissue sample such that removal of coring
component 650 causes the tissue sample to become completely
detached from the remainder of the target tissue.
[0078] In one exemplary embodiment, a surgeon may remove coring
component 650 from the target tissue by manually exerting a
longitudinal or rotational force on coring component 650. In other
embodiments, various components or mechanisms may be included in
biopsy device 600 which provide the surgeon with the ability to
remove coring component 650 from the target tissue. In particular,
any of the components or mechanisms discussed above which permit a
surgeon to insert coring component 650 into the target tissue, or
which are used to extend coring component 650 to the target tissue,
may also be used to remove the coring component from the target
tissue.
[0079] Following extraction of the tissue sample, biopsy device 600
and the tissue sample may be removed from the patient. In these
embodiments, biopsy device 600 may include one or more mechanisms
or elements which permit a surgeon to guide the biopsy device from
the patient. For example, any of the articulation elements or
mechanisms described above with reference to FIGS. 4A-4C may be
further used by the surgeon to guide biopsy device 600 from the
patient.
[0080] As noted, in embodiments of the present invention, a lumen
extends through catheter 604 that is operationally contiguous with
a lumen of coring component 650. The operational contiguity of the
lumens allows a surgeon to use the lumen during the biopsy
procedure. For example, in certain embodiments, various devices may
be inserted through the contiguous lumens such as optical devices,
probes, forceps, needles, brushes, etc. Furthermore, the contiguous
lumens permit a surgeon to deliver various treatments there
through, before, during or after the obtaining the tissue
sample.
[0081] FIG. 7A is a front perspective view of a coring component
750A in accordance with particular embodiments of FIG. 6. As shown
in FIG. 7A, coring component 750A comprises an elongate element
having longitudinal lumen terminating in a distal opening 766. A
distal region of coring component 750A is formed of a blade
arrangement 764.
[0082] As shown in FIG. 7A, blade arrangement 764 comprises an
elongate shaft 730 and plurality of distally extending blades 761
having their distal ends positioned around opening 766 of coring
component 750A. In some embodiments, the distal ends of blades 761
are radially positioned around opening 766. The distal end of each
blade 761 is a cutting edge 765. As shown in FIG. 7A, blade
arrangement 764 comprises four blades 761. However, it should be
appreciated that blade arrangement 764 may comprise more or less
blades 761.
[0083] In the illustrated embodiment, each blade 761 has an
approximately lunate cross-section. In other embodiments, each
blade 761 has a cross-section of other geometries or shapes.
Likewise in embodiments of the present, the cross-sections of each
blade are not uniform. As shown, the concave portion of each blade
is proximate to the lumen of coring component 750A.
[0084] As described above with reference to FIG. 6, blade
arrangement 764 is configured to penetrate the target tissue such
that a portion of the target tissue having a cross-section defined
by the distal end of blade arrangement 764 is received within the
lumen of coring component 750A via distal opening 766. Also, as
noted above, blade arrangement 764 is configured to substantially
sever the portion of the target tissue received within coring
component 750A, referred to as the tissue sample, from the
remainder of the target tissue.
[0085] Blade arrangement 764 may substantially sever the tissue
sample from the target tissue in a variety of manners. For example,
in certain embodiments, coring component 750A is rotatable with
respect to the target tissue. In response to the rotation of coring
component 750A, cutting edges 765 of blades 761 substantially
reduce the cross-sectional diameter of the portion of the target
tissue positioned there between proximate to opening 766.
[0086] In the same or other embodiments, blade arrangement 764 may
substantially sever the tissue sample via closure of blades 761 to
obtain a tissue sample suitable for proper examination. As noted
above, certain sampling devices are unable to obtain large enough
samples suitable for all types of examination.
[0087] In the illustrated embodiments, at least one blade 761 is
configured to flex inwardly towards a longitudinal axis extending
through coring component 750A. The inward flexing of one or more
blades 761 causes blades 761 to cut through the target tissue
positioned there between so as to substantially sever the tissue
sample from the remainder of the target tissue. These embodiments
are described below in more detail with reference to FIGS. 8A and
8B.
[0088] In certain embodiments of FIG. 7A, each blade 761 is
separated from adjacent blades by an elongate slit 762. Elongate
slit 762 extends from opening 766 to a substantially circular
aperture 760. Aperture 760 may enhance the inward flexing of one or
more blades 761 during penetration of blades 761.
[0089] In certain embodiments of the present invention, the tissue
sample may be substantially severed from the target tissue via a
combination of inward flexing of one or more blades 761 and
rotation of coring component 750A.
[0090] As explained above with reference to FIG. 2B, following
substantial severing of the tissue sample, the tissue sample is
extracted from the target tissue by removing coring component 750A
from the target tissue. As discussed above with reference to FIG.
6, coring component 750A may be removed from the target tissue in a
variety of manners. In particular, any of the components or
mechanisms discussed above which permit a surgeon to insert or
remove coring component 650 may also be used to remove coring
component 750A from the target tissue.
[0091] As noted above, because blade arrangement 764 substantially
severs the tissue sample, the tissue sample may remain partially
attached to the remainder of the target tissue. As such, coring
component 750A is configured to firmly secure the tissue sample
such that the tissue sample is completely detached from the
remainder of the target tissue during removal of coring component
750A from the target tissue.
[0092] In certain embodiments, blade arrangement 764 may firmly
secure the tissue sample so as to permit detachment of the tissue
sample from the remainder of the target tissue. In other
embodiments, as shown in FIG. 7A, coring component 750A may further
include a retention feature 768 to assist in the extraction of the
tissue sample. In these embodiments, following penetration of blade
arrangement 764 into the target tissue, retention feature 768
secures the tissue sample within the lumen of coring component
750A. During removal of coring component 750A from the target
tissue, retention feature 768 remains secured to the tissue sample,
thereby exerting an additional force on the tissue sample and
further ensuring that the tissue sample is fully detached from the
remainder of the target tissue. Tissue retention feature 768 has
the further advantage of substantially preventing the tissue sample
from being detached from the device during removal of the device
from the patient.
[0093] In the illustrated embodiment of FIG. 7A, retention feature
768 may comprise a textured surface 768 of at least a portion of
blade arrangement 764. More specifically, textured surface 768 may
comprise a textured portion of a surface of one or more blades 761
adjacent the lumen of coring component 750A. In these embodiments,
textured surface 768 attaches to the tissue sample and assists in
securing the tissue sample within coring component 750A.
[0094] Various embodiments of retention feature 768 are within the
scope of the present invention. For example, in one exemplary
embodiment, retention feature 768 may comprise an adhesive applied
to at least a portion of blade arrangement 768. In these
embodiments, the adhesive has an adhesive force configured to
secure tissue sample within coring component 750A, but which may be
overcome by a surgeon with sufficient manual force following
removal of coring component 750A from the patient. In these
embodiments, retention feature 768 may comprise a reusable
adhesive, such as a Gecko-Mussel adhesive.
[0095] In further embodiments, retention feature 768 may comprise a
suction system included in the biopsy device configured to provide
suction at or near coring component 750A. For example, in one such
embodiment, suction may be provided through the lumen of coring
component 750A to exert a force on the tissue sample and to assist
in retaining the tissue sample therein. In other embodiments,
suction may be provided around coring component 750A. Embodiments
in which suction may be provided are described in more detail below
with reference to FIGS. 13A-13C.
[0096] In other embodiments, retention feature 768 may comprise one
or more additional elements at or in coring component 750A. For
example, in one such embodiment, retention feature 768 may comprise
a needle positioned within coring component 750A to secure the
tissue sample within the lumen of coring component 750A. These
embodiments are described below in more detail with reference to
FIGS. 11A and 11B.
[0097] In other such embodiments, retention feature 768 may
comprise a pair of opposing jaws. In these embodiments, opposing
jaws are positioned within coring component 750A and are configured
to secure the tissue sample within coring component 750A by
attaching to at least a portion of the tissue sample. These
embodiments are described below in more detail with reference to
FIGS. 10A and 10B.
[0098] In still other embodiments, retention feature 768 may
comprise one or more barbs or spikes provided on blade arrangement
764. These embodiments are described below with reference to FIGS.
7B and 7C.
[0099] Furthermore, as noted above, each blade 761 includes cutting
edges 765 disposed at the distal end there of blades 761. It should
be appreciated that each blade 761 may also include additional
cutting edges. For example, each blade may include one or more
longitudinally extending cutting edges.
[0100] FIG. 7B is a perspective view of a coring component 750B in
accordance with certain embodiments of FIG. 6. As shown in FIG. 7B,
coring component 750B comprises an elongate element having a
longitudinal lumen terminating in a distal opening 776. A distal
region of coring component 732 is formed of a blade arrangement
764.
[0101] As shown in FIG. 7B, blade arrangement 774 comprises a
plurality of distally extending blades 770 having their distal ends
positioned around distal opening 776 of coring component 750B. The
distal end of each blade 770 is a cutting edge 775. As shown in
FIG. 7B, blade arrangement 774 comprises a pair of opposing blades
770. In some embodiments, the distal ends of blades 761 are
radially positioned around opening 776. However, it should be
appreciated that blade arrangement 770 may comprise more or less
blades 770.
[0102] In the illustrated embodiment, each blade 770 has an
approximately lunate cross-section. In other embodiments, each
blade 770 has a cross-section of other geometries or shapes.
Likewise in embodiments of the present, the cross-sections of each
blade are not uniform. As shown, the concave portion of each blade
is proximate to the lumen of coring component 750B.
[0103] Also, in particular embodiments illustrated in FIG. 7B, the
distal region of each blade 770 adjoining cutting edges 775
comprises a non-planar surface. For example, as described in more
detail with reference to FIG. 8A, the distal region of blades 770
may comprise a curved or beveled surface 773 (generally and
collectively referred to herein as a "beveled surface").
[0104] As described above with reference to FIGS. 6 and 7A, blade
arrangement 774 is configured to penetrate the target tissue such
that a portion of the target tissue having a cross-section defined
by the distal end of blade arrangement 774 is received within the
lumen of coring component 750B via distal opening 766. Also, as
noted above, blade arrangement 774 is configured to substantially
sever the portion of the target tissue received within coring
component 750B, referred to as the tissue sample, from the
remainder of the target tissue.
[0105] Blade arrangement 774 may substantially sever the tissue
sample from the target tissue in a variety of manners. For example,
in certain embodiments, coring component 750B is configured to be
rotatable with respect to the target tissue. In response to the
rotation of coring component 750B, cutting edges 775 of blades 770
substantially reduce the cross-sectional diameter of the portion of
the target tissue positioned there between proximate to distal
opening 776.
[0106] In the same or other embodiments, blade arrangement 774 may
substantially sever the tissue sample via closure of blades 770. In
these embodiments, at least one blade 770 is configured to flex
inwardly towards a longitudinal of coring component 750B. In
specific embodiments, the at least one blade flexes inwards towards
a longitudinal axis through a geometric center of opening 776. The
inward flexing of one or more blades 770 causes blades 770 to cut
through the target tissue positioned there between so as to
substantially sever the tissue sample from the remainder of the
target tissue. These embodiments are described below in more detail
with reference to FIGS. 8A and 8B.
[0107] In certain embodiments of the present invention, the tissue
sample may be substantially severed from the target tissue via a
combination of inward flexing of one or more blades 770 and
rotation of coring component 750B.
[0108] As described above with reference to FIG. 2B, following
substantial severing of the tissue sample, the tissue sample is
extracted from the target tissue by removing coring component 750B
from the target tissue. As described above with reference to FIG.
7A, coring component 750B may be removed from the target tissue in
a variety of manners.
[0109] Because blade arrangement 774 substantially severs the
tissue sample, the tissue sample may remain partially attached to
the remainder of the target tissue. As such, coring component 750B
is configured to firmly secure the tissue sample so that the tissue
sample is completely detached from the remainder of the target
tissue during removal of coring component 750B.
[0110] In other embodiments, coring component 750B may further
include a retention feature 778 to assist in the extraction of the
tissue sample. In these embodiments, following penetration of blade
arrangement 774 into the target tissue, retention feature 778
secures the tissue sample within the lumen of coring component
750B. During removal of coring component 750B from the target
tissue, retention feature 778 remains secured to the tissue sample
thereby exerting an additional force on the tissue sample and
further ensuring that the tissue sample is fully detached from the
remainder of the target tissue.
[0111] As shown in FIG. 7B, retention feature 778 comprises a
plurality of barbs 778 positioned on the surface of blades 770
adjacent the lumen of coring component 750B. In these embodiments,
following penetration of blades 770 into the target tissue, barbs
778 attach to the tissue sample. When the surgeon removes coring
component 750B from the target tissue, barbs 778 exert a force on
the tissue sample to retain the tissue sample within coring
component 750B.
[0112] In the specific embodiment illustrated in FIG. 7B, barbs 778
are positioned on blades 770 such that the point of each barb at
least partially faces away from opening 776. As such, when barbs
778 adhere to the tissue sample, barbs 778 exert a force on the
tissue sample in a direction substantially opposite the remainder
of the target tissue.
[0113] Although FIG. 7B has been described with reference to barbs
778, it should be appreciated that other retention features may
also be used with coring component 750B. For example, as described
above with reference to FIG. 7A, coring component 750B may further
include a textured surface, an adhesive applied to at least a
portion of blade arrangement 774, a needle or a set of opposing
jaws positioned within coring component, spikes, etc. In other
embodiments, suction may be provided by the biopsy device to retain
the tissue sample in coring component 750B.
[0114] In the illustrated embodiments, each blade 770 includes
cutting edges 775 disposed at the distal end there of blades 770.
It should be appreciated that each blade 770 may also include
additional cutting edges. For example, each blade may include one
or more longitudinally extending cutting edges.
[0115] FIG. 7C is a perspective view of a coring component 750C in
accordance with certain embodiments of FIG. 6. As shown in FIG. 7C,
coring component 750C comprises an elongate element having a
longitudinal lumen terminating in a distal opening 786. A distal
region of coring component 750C is formed of a blade arrangement
784.
[0116] As shown in FIG. 7C, blade arrangement 784 comprises a
plurality of distally extending blades 780 having their distal ends
positioned around distal opening 786 of coring component 750C. The
distal end of each blade 761 is a cutting edge 785. In some
embodiments, the distal ends of blades 761 are radially positioned
around opening 786. As shown in FIG. 7C, blade arrangement 784
comprises a pair of opposing blades 780. However, it should be
appreciated that blade arrangement 780 may comprise more or less
blades 780.
[0117] In the illustrated embodiment, each blade 780 has an
approximately lunate cross-section. In other embodiments, each
blade has a cross-section of other geometries or shapes. Likewise
in embodiments of the present, the cross-sections of each blade are
not uniform. As shown, the concave portion of each blade is
proximate to the lumen of coring component 750C.
[0118] As described above with reference to FIGS. 6-7B, blade
arrangement 784 is configured to penetrate the target tissue such
that a portion of the target tissue having a cross-section defined
by the distal end of blade arrangement 784 is received within the
lumen of coring component 750C via distal opening 786. Also, as
noted above, blade arrangement 784 is configured to substantially
sever the portion of the target tissue received within coring
component 750C, referred to as the tissue sample, from the
remainder of the target tissue.
[0119] Blade arrangement 784 may substantially sever the tissue
sample in a variety of manners. For example, as noted above, in
certain embodiments, coring component 750C is rotatable with
respect to the target tissue. In response to the rotation of coring
component 750C, cutting edges 785 of blades 780 substantially
reduce the cross-sectional diameter of the portion of the target
tissue positioned there between proximate to opening 776.
[0120] In the same or other embodiments, blade arrangement 784 may
substantially sever the tissue sample via closure of blades 780. In
these embodiments, at least one blade 780 is configured to flex
inwardly towards a longitudinal axis of coring component 750C. In
specific embodiments, one or more blades flex inwardly towards an
axis extending through the geometric center of opening 786. The
inward flexing of one or more blades 780 causes blades 780 to cut
through the target tissue positioned there between so as to
substantially sever the tissue sample from the remainder of the
target tissue. These embodiments are described below in more detail
with reference to FIGS. 8A and 8B.
[0121] In certain embodiments of the present invention, the tissue
sample may be substantially severed from the target tissue via a
combination of inward flexing of one or more blades 780 and
rotation of coring component 750C.
[0122] As explained above with reference to FIG. 2B, following
substantial severing of the tissue sample, the tissue sample may be
extracted from the target tissue by removing coring component 750C
from the target tissue. As described above with reference to FIG.
7A, coring component 750C may be removed from the target tissue in
a variety of manners.
[0123] As noted above, because blade arrangement 784 substantially
severs the tissue sample, the tissue sample may remain partially
attached to the remainder of the target tissue. As such, coring
component 750C is configured to firmly secure the tissue sample
such that the tissue sample is completely detached from the
remainder of the target tissue during removal of coring component
750C.
[0124] In other embodiments, coring component 750C may further
include a tissue retention feature 788 to assist in the extraction
of the tissue sample from the target tissue. In these embodiments,
following penetration of blade arrangement 784 into the target
tissue, retention feature 788 secures the tissue sample within the
lumen of coring component 750C. During removal of coring component
750C from the target tissue, retention feature 788 remains secured
to the tissue sample, thereby exerting an additional force on the
tissue sample and further ensuring that the tissue sample is fully
detached from the remainder of the target tissue.
[0125] As shown in FIG. 7C, retention feature 788 comprises
opposing barbs 788, each positioned on the surface of blades 780
adjacent opening 786. In these embodiments, following penetration
of blades 780 into the target tissue, barbs 788 attach to the
tissue sample. When the surgeon removes coring component 750C from
the target tissue, barbs 788 exert a force on the tissue sample to
retain the tissue sample within the lumen of coring component
750C.
[0126] In the specific embodiment illustrated in FIG. 7C, barbs 788
are positioned on blades 780 such that the point of each barb at
least partially faces away from opening 786. As such, when barbs
788 attach to the tissue sample, barbs 788 exert a force on the
tissue sample in a direction substantially opposite the remainder
of the target tissue.
[0127] Although FIG. 7C has been described with reference to
opposing barbs 788, it should be appreciated that additional barbs
may be included on each blade 780 to retain the tissue sample
within coring component 750C. Also, it should be appreciated that
other retention features may also be used with coring component
750C. For example, as described above with reference to FIG. 7A,
coring component 750C may further include a textured surface, an
adhesive applied to at least a portion of blade arrangement 784, a
needle or a set of opposing jaws positioned within coring component
750C, hooks, spikes, etc. In other embodiments, suction may be
provided by a biopsy device having coring component 750C therein so
as to retain the tissue sample within the lumen of the coring
component.
[0128] Furthermore, as noted above, each blade 780 includes cutting
edges 785 disposed at the distal end there of blades 780. It should
be appreciated that each blade 780 may also include additional
cutting edges. For example, each blade may include one or more
longitudinally extending cutting edges.
[0129] In accordance with embodiments of the present invention
illustrated in FIGS. 7A-7C, coring components 750 may be
permanently connected to a catheter. In other embodiments, coring
components 750 may be removably connected to a catheter.
[0130] FIGS. 8A and 8B are perspective views of embodiments of
coring components 850 in accordance with certain embodiments of the
present invention. In particular, FIGS. 8A and 8B illustrate
embodiments of coring components 850 configured to sever a tissue
sample via closure of elements of coring components 850.
[0131] As shown in FIG. 8A, coring component 850A comprises an
elongate element 830 having a longitudinal lumen terminating in a
distal opening. A distal region of element 830 is formed of a blade
arrangement 874 having one or more cutting edges 875 positioned
around the distal opening of coring component 850A. In the
illustrated embodiment, blade arrangement 874 comprises a pair of
opposing blades 870 each having an approximately lunate
cross-section. In the embodiments of FIG. 8A, prior to penetration
of blades 870 into the target tissue, the distal end of blades 870
are positioned around the distal opening of coring component
850A.
[0132] As discussed above with reference to FIG. 7B, blade
arrangement 874 is configured to penetrate the target tissue such
that a portion of the target tissue having a cross-section defined
by an inner diameter of the distal end of blade arrangement 874 is
received within the lumen of coring component 850A via the distal
opening of coring component 850A. Also, as noted above, blade
arrangement 874 is configured to substantially sever the portion of
the target tissue received within coring component 850A, referred
to as the tissue sample, from the remainder of the target
tissue.
[0133] In the embodiments illustrated in FIG. 8A, blade arrangement
874 may substantially sever the tissue sample via closure of blades
870. In these embodiments, one or more of blades 870 are configured
to flex inwardly towards a longitudinal axis of coring component
850A, shown as axis 891. For example, one or more blades 870 may
flex inwards towards a longitudinal axis through the geometric
center of coring component 850A. In the specific embodiment of FIG.
8A, both blades 870 flex inwards toward longitudinal axis 891. The
inward flexing of blades 870 causes blades 870 to cut through the
target tissue positioned there between so as to substantially sever
the tissue sample from the remainder of the target tissue.
[0134] In particular embodiments illustrated in FIG. 8A, blades 870
are configured to flex inwardly during penetration of the target
tissue. In certain such embodiments, blades 870 each comprise a
curved or beveled surface 873 (generally and collectively referred
to as a "beveled surface" herein). As blades 870 are inserted into
the target tissue, the target tissue adjoining beveled surfaces 873
exert a force on the beveled surfaces in the direction of
longitudinal axis 891. This force exerted by the target tissue on
beveled surfaces 873 increases as blades 870 penetrate deeper into
the target tissue.
[0135] As the force on bevel surfaces 873 increase, the beveled
surfaces are forced inwardly towards axis 891. Each blade has
sufficient strength such that as beveled surfaces 873 flex towards
axis 891, cutting edges of blades 870 cut through the target
tissue. As shown in FIG. 8A, following penetration of blades 870 to
a predetermined depth, the distal ends of blades 870 are positioned
substantially adjacent axis 891.
[0136] In accordance with other embodiments illustrated in FIG. 8A,
blades 870 are configured to flex inwards following penetration of
the target tissue by blades 870. In one such embodiment, blades 870
comprise a shape memory material configured to flex inwardly toward
axis 891 following insertion. Blades 870 may flex inwardly in
response to, for example, a change in temperature induced by the
target tissue. In another such embodiment, blades 870 may flex
inwardly in response to application of an electrical current to
blades 870.
[0137] The inward flexing of blades 870 causes coring component
850A to obtain a tissue sample that is large enough for proper
examination following the procedure. Furthermore, the inward
flexing of blades 870 help to ensure that the tissue sample remains
within the lumen during removal of the device from the patient.
[0138] As explained above, following substantial severing of the
tissue sample, the tissue sample is extracted from the target
tissue by removing coring component 850A from the target tissue. As
described above with reference to FIG. 7A, coring component 850A
may be removed from the target tissue in a variety of manners.
[0139] As noted above, each blade 870 includes cutting edges 875
disposed at the distal end thereof. It should be appreciated that
each blade 870 may also include additional cutting edges. For
example, as shown in FIG. 8A, each blade may include one or more
longitudinally extending cutting edges, shown as cutting edges 877
in FIG. 8A. Cutting edges 877 and 875 may collectively cut through
the target tissue as blades 870 flex inwardly.
[0140] In certain embodiments of the present invention, the tissue
sample may be substantially severed from the target tissue via a
combination of inward flexing of blades 870 and rotation of coring
component 850A.
[0141] FIG. 8B illustrates an alternative coring component 850B in
which a tissue portion received therein, referred to as the tissue
sample, may be substantially severed via closure of blades 880 of
coring component 850B. As shown in FIG. 8B, coring component 850B
comprises an elongate element 832 having a longitudinal lumen
terminating in a distal opening. A distal region of elongate
element 832 is formed of a blade arrangement 884 having one or more
cutting edges 885 positioned around the distal opening of coring
component 850A. In the illustrated embodiment, blade arrangement
884 comprises a pair of opposing blades each having an approximate
lunate cross-section.
[0142] As discussed above with reference to FIG. 7B, blade
arrangement 884 is configured to penetrate the target tissue such
that a portion of the target tissue having a cross-section defined
by the distal end of blade arrangement 884 is received within the
lumen of coring component 850B via the distal opening. Also, as
noted above, blade arrangement 884 is configured to substantially
sever the portion of the target tissue received within coring
component 850B, referred to as the tissue sample, from the
remainder of the target tissue.
[0143] In the embodiments illustrated in FIG. 8B, blade arrangement
884 may substantially sever the tissue sample via closure of blades
880. In these embodiments, one or more of blades 880 are configured
to flex inwardly towards a longitudinal axis of coring component
850B, shown as axis 891. The inward flexing of blades 880 causes
the blades to cut through the target tissue positioned there
between so as to substantially sever the tissue sample from the
remainder of the target tissue.
[0144] In particular embodiments illustrated in FIG. 8B, blades 880
are configured to flex inwardly during penetration of the target
tissue. In certain such embodiments, blades 880 each comprise a
beveled surface 883. As blades 880 are inserted into the target
tissue, the target tissue adjoining beveled surfaces 883 exert a
force on the beveled surfaces in the direction of axis 891. This
force exerted by the target tissue on beveled surfaces 883
increases as blades 880 penetrate deeper into the target
tissue.
[0145] As the force on bevel surfaces 883 increase, beveled
surfaces 883 flex inwardly towards longitudinal axis 891. Each
blade has sufficient strength such that as beveled surfaces 883
flex towards axis 891, cutting edges of blades 880 cut through the
target tissue. As shown in FIG. 8B, following penetration of blades
880 to a predetermined depth, the distal ends of blades 880 are
positioned substantially adjacent axis 891.
[0146] In accordance with other embodiments illustrated in FIG. 8B,
blades 880 are configured to flex inwards following penetration of
the target tissue by blades. In these embodiments, blades 880
comprise a shape memory material configured to flex inwardly toward
axis 891 following insertion. In one such embodiment, following
penetration, blades 880 flex inwardly in response to a change in
temperature induced by the target tissue. In another such
embodiment, blades 880 may flex inwards in response to application
of an electrical current to blades 880.
[0147] As shown in FIG. 8B, in certain embodiments coring component
850B comprises a two-piece component comprising opposing elements
881. Opposing elements 881 collectively define the longitudinal
lumen extending there through. In the embodiments of FIG. 8B,
elements 881 are connected to one another via a hinge arrangement
889. In certain embodiments, hinge arrangement 889 enhances the
ability of blades 880 to flex inwards in response to forces on
beveled surfaces 883 during penetration. In other embodiments,
hinge arrangement 889 enhances the response of blades comprising
shape memory materials to changes in temperature or to an
electrical current.
[0148] In other embodiments, hinge arrangement 889 provides a
surgeon with the ability to mechanically close blades 880. In
certain embodiments, a biopsy device having coring component 850B
therein includes a component which permits a surgeon to actuate
hinge arrangement 889. Actuation of hinge arrangement 889 causes
the distal ends of one or more of blades 880 to flex inwards
towards axis 891. In such embodiments, the proximal ends 889 of
elements 881 are forced away from axis 891, shown by directional
arrows 890, 892. In embodiments of the present invention, the
surgeon may actuate hinge mechanism during or following penetration
of the target tissue by blades 880.
[0149] In certain embodiments of the present invention, the tissue
sample may be substantially severed from the target tissue via a
combination of inward flexing of blades 880 and rotation of coring
component 850B.
[0150] In the above embodiments, the inward flexing of blades 880
causes coring component 850B to obtain a tissue sample that is
large enough for proper examination following the procedure.
Furthermore, the inward flexing of blades 880 help to ensure that
the tissue sample remains within the lumen during removal of the
device from the patient.
[0151] As explained above, following the substantially severing of
the portion of the target tissue received within coring component
850B, the tissue portion is extracted from the target tissue by
removing coring component 850B from the target tissue. As described
above with reference to FIG. 7A, coring component 850B may be
removed from the target tissue in a variety of manners.
[0152] As noted above with reference to FIGS. 3A and 3B, an
endoscopic biopsy device in accordance with embodiments of the
present invention may be anchored or secured to a target tissue
prior to sampling of the target tissue. FIG. 9 illustrates a distal
portion of embodiments of an endoscopic biopsy device 900 including
an anchoring element 960.
[0153] As noted above, an endoscopic biopsy device in accordance
with embodiments of the present invention, such as biopsy device
900, includes a sheath 902, a catheter 904 and a sampling component
950 positioned at the distal end of catheter 904. In the
illustrated embodiment, sampling component 950 comprises a coring
component 950.
[0154] As shown below, anchoring element 960 causes biopsy device
900 to be located at the proper location prior to insertion of the
coring component 950 into the target tissue. Furthermore, anchoring
element 960 prevents coring component 950 from slip, sliding or
moving relative to the target tissue immediately before or during
penetration.
[0155] In the embodiment of FIG. 9, during insertion of biopsy
device 900 into the patient, coring component 950 is positioned
within sheath 902. Biopsy device 900 is inserted into the patient
until a distal end of sheath 902 is positioned in contact with a
target tissue. While in contact with the target tissue, anchoring
element 960 secures biopsy device 900 with respect to the target
tissue.
[0156] As shown in FIG. 9, anchoring element 960 comprises a
plurality of spikes 960 positioned on the distal end of sheath 902.
When sheath 902 is placed in contact with the target tissue, spikes
960 attach or secure sheath 902 to the target tissue. Spikes 960
are configured to remain attached to the target tissue at least
until coring component 950 penetrates the target tissue. Spikes 960
are further configured to be detached from the target tissue with
minimal damage to the target tissue.
[0157] In certain embodiments, spikes 960 are fixed spikes
positioned permanently at the distal end of sheath 902. In other
embodiments, spikes 960 comprise retractable spikes configured to
be extended from, and withdrawn into, sheath 902.
[0158] Although FIG. 9 has been discussed herein with reference to
spikes 960, it should be appreciated that anchoring element 960 may
further comprise a variety of additional embodiments. For example,
in certain embodiments, anchoring element 960 may comprise a
textured surface positioned at the distal end of sheath 902. In
these embodiments, the surface of the distal end of sheath 902 may
be modified so that sheath 902 will adhere to the target tissue.
This may include one or more rough portions, barbs etc.
[0159] In other embodiments, anchoring element 960 may comprise an
adhesive applied to the distal end of sheath 902. For example, in
such embodiments a reusable adhesive, such as a Gecko-Mussel
adhesive may be used.
[0160] Furthermore, although FIG. 9 has been discussed with
reference to an anchoring element 960 positioned at the distal end
of sheath 902, it should also be appreciated that coring component
950 may have an anchoring element 960 positioned thereon. In these
embodiments, sheath 902 would be positioned adjacent the target
tissue and coring component 950 would be at extended to the target
tissue. Prior to penetration of the target tissue by coring
component 950, anchoring element 960 on coring component 950 would
engage the target tissue. In such embodiments, anchoring element
960 retains coring component 950 in position with respect to the
target tissue during initial penetration. Anchoring element 960 of
such embodiments may include any of the anchoring elements
discussed above, including rough surface portions, spikes, barbs,
adhesive, etc. In certain such embodiments, the one or more blades
of coring component 950 may act alone to anchor coring component
950 to the target tissue prior to penetration.
[0161] As noted above with reference to FIG. 3B, certain
embodiments of the present invention may include an element
configured to be controllably extended from the biopsy device to
secure the biopsy device to the target tissue, referred to as an
extendible anchoring element. FIGS. 10A and 10B are front
perspective views of a distal region of an endoscopic biopsy device
1000 having such an extendible anchoring element, referred to as
anchoring element 1060.
[0162] Similar to embodiments described above, biopsy device 1000
comprises a sheath 1002 having a lumen there through. Extending
through the lumen is a catheter 1004 having a sampling component
1050 positioned at the distal end thereof. In the embodiments of
FIGS. 10A and 10B, sampling component 1050 comprises a coring
component 1050.
[0163] FIG. 10A illustrates the configuration of biopsy device 1000
prior to extension of anchoring element 1060. FIG. 10B illustrates
the configuration of biopsy device 1000 following extension of
anchoring element 1060, but prior to extension of coring component
1050 to the target tissue.
[0164] As shown in FIG. 10A, in a first configuration anchoring
element 1060 is positioned within coring component 1050. As noted
above, in embodiments of the present invention, catheter 104 and
coring component 1050 have a lumen extending therein. As shown in
FIGS. 10A and 10B, anchoring element 1060 may be positioned in this
lumen.
[0165] Anchoring element 1060 comprises an elongate shaft 1064 and
a pair of opposing jaws 1062. In these embodiments, a surgeon may
extend anchoring element 1060 from with the lumen of coring
component 1050 such that jaws 1062 contact the target tissue. Jaws
1062 may then be closed around a portion of the target tissue to
secure biopsy device 1000 to the target tissue. In embodiments
illustrated in FIGS. 10A and 10B, jaws 1062 close around a portion
of the target tissue such that coring component 1050 may penetrate
the target tissue around closed jaws 1062.
[0166] In certain embodiments of the present invention, jaws 1062
may release the target tissue during penetration of the target
tissue by coring component 1050. In other embodiments of the
present invention, jaws 1062 may remain attached to the target
tissue during and following penetration of the component. As such,
as described above with reference to FIGS. 6-7C, coring component
1050 is configured to substantially sever at least the portion of
the target attached to jaws 1062. In these embodiments, because
jaws 1062 remain attached to the severed tissue portion, jaws 1062
function as a retention feature to assist in the removal of the
severed portion from the target tissue.
[0167] Although FIGS. 10A and 10B have been described herein with
reference to a sampling component 1050 in the form of a coring
component, it should would be appreciated that anchoring element
1060 comprising jaws 1062 may be used in conjunction with
alternative sampling components. For example, in alternative
embodiments of the present invention, a sampling component in the
form of a jaws arrangement, such as the jaws arrangement described
with reference to FIG. 5, may be used in conjunction with anchoring
element 1060. In certain such embodiments, the anchoring element
1060 would be controllable extended from within the opposing jaws
of the jaws arrangement.
[0168] Furthermore, although anchoring element 1060 has been shown
extending from within coring component 1050, it should be
appreciated that anchoring may be extended from other locations as
well, such as adjacent the coring component, around the coring
component, etc.
[0169] FIGS. 11A and 11B are front perspective views of a distal
region of embodiments of an endoscopic biopsy device 1100 having an
extendible anchoring element, referred to as anchoring element
1160.
[0170] Similar to embodiments described above, biopsy device 1100
comprises a sheath 1102 having a lumen there through. Extending
through the lumen is a catheter (not shown) having a sampling
component 1150 positioned at the distal end thereof. In the
embodiments of FIGS. 11A and 11B, sampling component 1150 comprises
a coring component 1150.
[0171] FIG. 11A illustrates the configuration of biopsy device 1100
following extension of anchoring element 1160, but prior to
extension of coring component 1150. FIG. 11B illustrates the
configuration of biopsy device 1100 following extension anchoring
element 1160 and of coring component 1150. As shown, anchoring
element 1160 comprises a needle like component, referred to as
needle 1160. In these embodiments, a surgeon may extend needle 1160
from within coring component 1150 such that needle 1160 penetrates
a portion of the target tissue and remains secured therein. In
embodiments of the present invention, coring component 1150
penetrates the target tissue around needle 1160.
[0172] In certain embodiments of the present invention, needle 1160
may be removed from the target tissue during penetration of the
target tissue by coring component 1150. In other embodiments of the
present invention, needle 1160 may remain attached to the target
tissue during and following penetration of the component. In such
embodiments, coring component 1150 penetrates the target tissue
around needle 1160. As such, as described above with reference to
FIGS. 6-7C, coring component 1150 is configured to substantially
sever at least the portion of the target tissue attached to needle
1160. In these embodiments, because needle 1160 remains attached to
the severed tissue portion, needle 1160 functions as a retention
feature to assist in the removal of the severed portion from the
target tissue.
[0173] In the embodiments illustrated in FIGS. 11A and 11B, the
distal end of needle 1160 is curved. However, it should be
appreciated that other configurations for needle 1160 are within
the scope of the present invention. For example, in certain
embodiments, needle 1160 may be straight.
[0174] Furthermore, FIGS. 11A and 11B illustrate the use of a
single needle. However, it should also be appreciated that multiple
extendible needles may also be used in substantially the same
manner as described above. It should also be appreciated that in
embodiments of the present invention, needle 1160 may be net or
straight, solid or hollow wire, and may be integrated or separate
from any of sheath 1102, coring component 1150 or any other
utilized device.
[0175] Although FIGS. 11A and 11B have been described herein with
reference to a sampling component 1150 in the form of a coring
component, it should be appreciated that anchoring element 1160 may
be used in conjunction with alternative sampling components. For
example, in alternative embodiments of the present invention, a
sampling component in the form of a jaws arrangement, such as the
jaws arrangement described with reference to FIG. 5, may also be
used.
[0176] As shown in FIGS. 11A and 11B, anchoring element 1160
extends from within coring component 1150. However, it should be
appreciated that in other embodiments, anchoring element 1160 may
extend from other locations as well, such as adjacent to coring
component 1150.
[0177] FIGS. 12A and 12B illustrate the distal region of an
endoscopic biopsy device 1200 in accordance with embodiments of the
present invention. As show, biopsy device 1200 is similar to the
embodiments described above with reference to FIG. 5 and includes a
sheath 1202, and a jaws arrangement 1250. Jaws arrangement 1250
includes a shaft 504 and opposing jaws 512.
[0178] FIG. 12A illustrates the configuration of biopsy device 1200
prior to extension of anchoring element 1260 to the target tissue.
FIG. 12B illustrates the configuration of biopsy device 1200
following extension of anchoring element 1260, but prior to
extension of jaws arrangement 1250 to the target tissue.
[0179] As shown, anchoring element 1260 comprises a needle like
component, referred to as needle 1260. In these embodiments, a
surgeon may extend needle 1260 from within jaws arrangement 1250
such that needle 1260 penetrates a portion of the target tissue and
remains secured therein. In embodiments of the present invention,
jaws arrangement 1250 samples the portion of the target tissue
around needle 1260. More specifically, in the embodiments of FIGS.
12A and 12B, jaws 512 are positioned around the portion of the
target tissue attached to needle 1260. As explained above, closure
of jaws 512 substantially sever at least the portion of the target
tissue attached to needle 1260 from the remainder of the target
tissue.
[0180] In accordance with certain embodiments shown in FIGS. 12A
and 12B, needle 1260 may be extended from jaws arrangement 1250
through an aperture 1262 in jaws 1212. In these embodiments, needle
1260 may be extended to the target tissue without opening jaws
1212. Furthermore, in such embodiments, needle 1260 may be inserted
into the target tissue beyond jaws 1212 without interfering with
the closure of jaws 1212.
[0181] As shown, FIGS. 12A and 12B illustrate the use of a single
needle. However, it should also be appreciated that multiple
extendible needles may be used in substantially the same manner as
described above. It should also be appreciated that in embodiments
of the present invention, needle 1260 may be net or straight, solid
or hollow wire, and may be integrated or separate from any of
sheath 1202, coring component 1250 or any other utilized
device.
[0182] FIG. 13A illustrates a distal region of an endoscopic biopsy
device 1300A in which suction is provided via a biopsy port of the
device to secure the biopsy device to the target tissue and or to
secure a tissue sample within a coring component. In the
embodiments illustrated in FIG. 13A, biopsy device 1300A comprises
a sheath 1302 and a coring component 1350A. Extending through a
lumen of sheath 1302 is a catheter 1304 having coring component
1350A disposed at the distal end thereof. Coring component 1350A
comprises an element having a longitudinal lumen terminating in a
distal opening 1306. In the embodiments of FIG. 13A, a lumen of
catheter 1304 is operationally contiguous with the lumen of coring
component 1350A. As described above with reference to FIG. 6,
opening 1306 is configured to receive a portion of the target
tissue therein, referred to herein as a tissue sample.
[0183] As shown by arrows 1360A, suction is provided via opening
1306. In these embodiments, as coring component 1350A is extended
to the target tissue, the suction through opening 1306 causes
coring component 1350A to be secured to the target tissue.
[0184] In certain embodiments, the suction through opening 1306 may
be controlled by the surgeon. For example, in certain embodiments
the surgeon may control the magnitude of the suction. In other
embodiments, the surgeon may disable the suction during or
following penetration of coring component 1350A.
[0185] In other embodiments of the present invention, the suction
continues during penetration of the component. In these
embodiments, the suction functions as a retention feature to assist
in the removal of the tissue sample from the target tissue.
[0186] FIG. 13B illustrates another embodiment of the present
invention in which suction is provided via one or more openings in
a coring component 1350B of a endoscopic biopsy device 1300B to
secure the biopsy device to the target tissue. In the embodiments
illustrated in FIG. 13B, biopsy device 1300B comprises a sheath
1302 and a coring component 1350B. Extending through a lumen of
sheath 1302 is a catheter 1304 having coring component 1350B
positioned at the distal end thereof. In the embodiments of FIG.
13B, catheter 1304 and coring component 1350 have a lumen extending
longitudinally there through. The lumen terminates in an opening
1306.
[0187] In the embodiments illustrated in FIG. 13B, coring component
1350 comprises a plurality of openings 1310 therein. Openings 1310
are substantially perpendicular to a longitudinal axis through the
geometric center of opening 1306. As shown by arrows 1360B, suction
is provided via openings 1310. In these embodiments, as coring
component 1350B is extended to the target tissue, the suction
through openings 1310 causes coring component 1350B to be secured
to the target tissue.
[0188] In certain embodiments, the suction through openings 1310
may be controlled by the surgeon. For example, in certain
embodiments the surgeon may control the magnitude of the suction.
In other embodiments, the surgeon may disable the suction during or
following penetration of coring component 1350B.
[0189] In other embodiments of the present invention, the suction
continues during penetration of the component. In these
embodiments, the suction functions as a retention feature to assist
in the removal of the tissue sample from the target tissue.
[0190] FIG. 13C illustrates still other embodiments of the present
invention in which suction is provided via an endoscopic biopsy
device 1300C to secure the biopsy device to the target tissue. In
the embodiments illustrated in FIG. 13C, biopsy device 1300C
comprises a sheath 1302 and a coring component 1350C. Extending
through a lumen 1312 of sheath 1302 is a catheter 1304 having
coring component 1350C positioned at the distal end thereof. In the
embodiments of FIG. 13C, catheter 1304 and coring component 1350C
have a lumen extending longitudinally there through. The lumen
terminates in an opening 1306.
[0191] As shown by arrows 1360C, in the illustrated embodiment,
suction is provided around coring component 1350C via lumen 1312.
In these embodiments, as coring component 1350C is extended to the
target tissue, the suction through lumen 1312 around coring
component 1350C causes biopsy device 1300C to be secured to the
target tissue.
[0192] In certain embodiments, the suction through lumen 1312 may
be controlled by the surgeon. For example, in certain embodiments
the surgeon may control the magnitude of the suction. In other
embodiments, the surgeon may disable the suction during or
following penetration of coring component 1350C. In other
embodiments of the present invention, the suction continues during
penetration of the component.
[0193] Although FIGS. 13A-13C have been discussed reference to
coring components 1350, it should be appreciated that in
alternative embodiments other sampling components may also be used.
For example, in particular embodiments, a jaws arrangement, such as
the jaws arrangement described above with reference to FIG. 5 may
be used.
[0194] In one such embodiment in which a jaws arrangement may be
used in conjunction with suction, an internal lumen may be included
within the jaws arrangement to provide suction at the target tissue
between the opposing jaws of the jaws arrangement. In another
embodiment, suction may be provided around the jaws via a lumen of
a sheath.
[0195] An endoscopic biopsy device in accordance with embodiments
of the present invention may be further configured to deliver a
treatment to the target tissue prior to, during, or after sampling
of the target tissue. The treatment delivered to the target tissue
may take a variety of forms.
[0196] In certain embodiments of the present invention, the biopsy
device may be configured for hemostasis. For example, in one such
embodiment, the biopsy device may be configured to cauterize the
tissue at or near the sample during or after the sampling with the
sampling component. In alternative embodiments, the biopsy device
may be configured to apply a hemostasis coating at or near the
sample site to reduce the loss of blood. This coating may be
applied in a variety of ways including by applying an agent to the
biopsy sampling component prior to the sampling process, or by
spraying, injecting, misting or swabbing an agent onto the tissue.
As such, a variety of coating mechanisms may be incorporated into
the biopsy device.
[0197] In other embodiments of the present invention, biopsy device
may be further configured to deliver a therapeutic agent, marker or
other material to the target tissue. As described above with
reference to FIGS. 5 and 6, the catheter and sampling component may
have a lumen extending there through. As such, the therapeutic
agent, marker, diagnostic agent or other material may be delivered
via the lumen extending through catheter and sampling component.
These treatments may include, for example, antiseptic, anesthesia,
antibacterial or cleaning agents, rinse solutions, genetic or other
material in a solid, liquid, solution, gel, vapor, gas or any other
form.
[0198] In still other embodiments, the biopsy device may be further
configured to be to suture the sample site following sampling. This
suturing may be done by the coring component, or by one or more
components extending from in or near the coring component. As noted
above with reference to FIGS. 5 and 6, the catheter and sampling
component may have a lumen extending there through. As such, an
additional component for suturing the target tissue may be inserted
through this lumen.
[0199] As noted above, such treatments may be delivered through the
contiguous lumens of the catheter and the sampling components. In
other embodiments, an additional lumen may be provided through the
catheter and sampling component so as to provide an alternate
channel for delivery of treatments or which may otherwise be
utilized by a surgeon.
[0200] Furthermore, while various embodiments of the present
invention have been described above, it should be understood that
they have been presented by way of example only, and not
limitation. It will be apparent to persons skilled in the relevant
art that various changes in form and detail can be made therein
without departing from the spirit and scope of the invention. Thus,
the breadth and scope of the present invention should not be
limited by any of the above-described exemplary embodiments, but
should be defined only in accordance with the following claims and
their equivalents. All patents and publications discussed herein
are incorporated in their entirety by reference thereto.
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